Catalog Number

21810416

Brand Name

Monoart

Version/Model Number

MONOART® TOWEL UP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KHR

Product Code Name

Absorber, Saliva, Paper

Public Device Record Key

e521f45c-82f7-4607-b775-67e87ef3bb16

Public Version Date

December 25, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2019

Package DI Number

E307218104161

Quantity per Package

500

Contains DI Package

E307218104160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton